Descrizione Clinica
Medical devices - medical devices Hyalotend 3 sir 20mg/2ml Fidia
HYALOTEND
Description
Pre-filled syringe with solution of hyaluronic acid sodium salt for peritendineous use. Hyalotend consists of a viscose solution of sodium salt hyaluronic acid (500-730 kDa) obtained by bacterial fermentation, in a buffered physiological solution, by peritendinea injection. The solution (20 mg/2 ml) is contained in a pre-filled syringe and is supplied sterile. Hyaluronic acid is one of the main components of the synovial liquid, it is produced in the normal tendon sheath and is a main component of the extracellular matrix of the tendon. The administration of sodium salt of exogenous hyaluronic acid in peritendineous space, thanks to its viscoelastic properties, allows to reduce the surface friction of the tendons, increases the flowing capacity, reduces the pain and improves the tendine function in tendinopathy, thus accelerating the return to normal activities and sports. Hyalotend is indicated for the treatment of pain and the improvement of tendine elasticity in the tendinopathy of upper and lower limbs.
Composition
Hyaluronic acid salt sodium, sodium chloride, sodium bibasic phosphate dodecaidrate, sodium phosphate monobasic dihydrate, water for injectable preparations.
Mode of use
The administration of the product must be carried out exclusively by experienced medical personnel. Perform administration with an ultrasound probe to drive injection if necessary. All rules concerning aseptic administration should be closely followed. Do not use in conjunction with disinfectants containing quaternary ammonium salts, as hyaluronic acid may precipitate in their presence. Use a suitable sterile needle (21-25 G) according to medical advice. Throw the syringe and needle after single use.
Administer 3 peritendine injections of the product at weekly intervals, depending on your medical opinion. If necessary more tendons can be treated simultaneously,. Each syringe is intended for injection of a single tendon. Repeated treatments can be performed if required.
Warnings
Hyalotend should not be given to patients with hypersensitivity known to any product component. Hyalotend peritendine injections are contraindicated in case of infections or skin diseases in the injection site area. Hyalotend has not been tested on pregnant women or individuals under the age of 18 and is therefore contraindicated in these populations of patients. Do not use the product after the expiry date shown on the packaging. Do not use the product if the packaging is open or damaged: the sterility of the solution is guaranteed provided the package is closed and integrated. The syringe is disposable, which means it must be used for one injection. The assembled syringe must be eliminated immediately after use, regardless of whether the solution has been fully administered or not. If a syringe is used for a subsequent injection, there is a risk of contamination that could lead to disease, infection and/or serious damage to the patient. If the product is processed and/or used, Fidia Farmaceutici cannot guarantee its performance, functionality, structure of the material, cleaning or sterility. Reprocessing and/or reuse can cause serious damage to the patient's health and safety. After use dispose according to the applicable rules. As with any invasive procedure of the joint, it is recommended to pay attention not to overload the joint immediately after the peritendine injection. Keep out of reach of children. Local reactions such as pain and warmth or redness/inflator/ecchimosis may occur on the injection site. Usually such symptoms are transient and disappear spontaneously within a few days keeping to rest the affected joint and applying ice locally. After injection of hyaluronic acid, local or systemic allergic reactions due to individual hypersensitivity were sporadically recorded.
Conservation
The product must be stored at a temperature not exceeding 25 °C in the original packaging protected by light. Don't freeze.
Format
Cap containing 1 pre-filled syringe sealed in a blister.
Cap containing 3 pre-filled syringes, each sealed in a blister.
The solution 20 mg/2 ml of sodium salt hyaluronic acid contained in the pre-filled syringe is sterilized with steam.
Cod. 10000122, 10000123
Pre-filled syringe with solution of hyaluronic acid sodium salt for peritendineous use. Hyalotend consists of a viscose solution of sodium salt hyaluronic acid (500-730 kDa) obtained by bacterial fermentation, in a buffered physiological solution, by peritendinea injection. The solution (20 mg/2 ml) is contained in a pre-filled syringe and is supplied sterile. Hyaluronic acid is one of the main components of the synovial liquid, it is produced in the normal tendon sheath and is a main component of the extracellular matrix of the tendon. The administration of sodium salt of exogenous hyaluronic acid in peritendineous space, thanks to its viscoelastic properties, allows to reduce the surface friction of the tendons, increases the flowing capacity, reduces the pain and improves the tendine function in tendinopathy, thus accelerating the return to normal activities and sports. Hyalotend is indicated for the treatment of pain and the improvement of tendine elasticity in the tendinopathy of upper and lower limbs.
Composition
Hyaluronic acid salt sodium, sodium chloride, sodium bibasic phosphate dodecaidrate, sodium phosphate monobasic dihydrate, water for injectable preparations.
Mode of use
The administration of the product must be carried out exclusively by experienced medical personnel. Perform administration with an ultrasound probe to drive injection if necessary. All rules concerning aseptic administration should be closely followed. Do not use in conjunction with disinfectants containing quaternary ammonium salts, as hyaluronic acid may precipitate in their presence. Use a suitable sterile needle (21-25 G) according to medical advice. Throw the syringe and needle after single use.
Administer 3 peritendine injections of the product at weekly intervals, depending on your medical opinion. If necessary more tendons can be treated simultaneously,. Each syringe is intended for injection of a single tendon. Repeated treatments can be performed if required.
Warnings
Hyalotend should not be given to patients with hypersensitivity known to any product component. Hyalotend peritendine injections are contraindicated in case of infections or skin diseases in the injection site area. Hyalotend has not been tested on pregnant women or individuals under the age of 18 and is therefore contraindicated in these populations of patients. Do not use the product after the expiry date shown on the packaging. Do not use the product if the packaging is open or damaged: the sterility of the solution is guaranteed provided the package is closed and integrated. The syringe is disposable, which means it must be used for one injection. The assembled syringe must be eliminated immediately after use, regardless of whether the solution has been fully administered or not. If a syringe is used for a subsequent injection, there is a risk of contamination that could lead to disease, infection and/or serious damage to the patient. If the product is processed and/or used, Fidia Farmaceutici cannot guarantee its performance, functionality, structure of the material, cleaning or sterility. Reprocessing and/or reuse can cause serious damage to the patient's health and safety. After use dispose according to the applicable rules. As with any invasive procedure of the joint, it is recommended to pay attention not to overload the joint immediately after the peritendine injection. Keep out of reach of children. Local reactions such as pain and warmth or redness/inflator/ecchimosis may occur on the injection site. Usually such symptoms are transient and disappear spontaneously within a few days keeping to rest the affected joint and applying ice locally. After injection of hyaluronic acid, local or systemic allergic reactions due to individual hypersensitivity were sporadically recorded.
Conservation
The product must be stored at a temperature not exceeding 25 °C in the original packaging protected by light. Don't freeze.
Format
Cap containing 1 pre-filled syringe sealed in a blister.
Cap containing 3 pre-filled syringes, each sealed in a blister.
The solution 20 mg/2 ml of sodium salt hyaluronic acid contained in the pre-filled syringe is sterilized with steam.
Cod. 10000122, 10000123
